Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) Versus Intravenous Chemotherapy in Unresectable Peritoneal Metastases Secondary to Platinum-Resistant Ovarian Cancer: Interim Analysis of Randomized Controlled Trial.

Abstract

Introduction: Platinum-resistant ovarian cancer (PROC) with peritoneal metastasis has limited therapeutic options, with poor response rates and significant toxicity from systemic chemotherapy. PIPAC has emerged as a locoregional strategy to improve intraperitoneal drug delivery.

Methods: This randomized study (CTRI REF/2018/08/021223) included patients with unresectable peritoneal metastases secondary to PROC. Patients were randomized to PIPAC or systemic intravenous chemotherapy. The primary endpoint was objective response rate (ORR) assessed by RECIST 1.1. Secondary endpoints included quality of life (EORTC QLQ-C30) and treatment-related morbidity (CTCAE v4.0 and Clavien-Dindo classification).

Results: We had Eighty patients (40 per arm) with comparable baseline characteristics. ORR was significantly higher in the PIPAC arm compared to intravenous chemotherapy (62.5% vs. 15%; OR 9.44, 95% CI 3.21-27.77, p < 0.001). Disease control rate was also superior (85% vs. 45%; p < 0.001). Histopathological response (PRGS 1-2) was observed in 60% of patients receiving PIPAC. QOL demonstrated significant improvement in global health scores at Day 120 in the PIPAC group (mean difference 10.5; p < 0.001). Grade ≥ 3 adverse events were lower with PIPAC (12.5% vs. 42.5%; OR 0.19, 95% CI 0.06-0.60, p = 0.005).

Conclusion: In this interim analysis, of Indian Randomised Control study, PIPAC demonstrated a consistent signal of improved tumor response, better quality of life, and reduced severe toxicity compared with intravenous chemotherapy. PIPAC is a very useful option in PROC giving good response rate and outcome with better quality of life. In future RCT's it would be interesting to explore bidirectional treatment with concomitant PIPAC and IV Chemotheraphy in recurrent ovarian cancer.